Clinical Trial Manager (contract)

Valid8 Financial, Inc.; South San Francisco (CA); On-site; USD 80,000 - 113,000; Full time

Job summary

ALX Oncology seeks a contract Clinical Trial Manager to oversee day-to-day global trial operations from start-up through closeout. You will coordinate activities, manage timelines and vendors, and ensure milestones are met with high quality.

This 6–12 month role offers about 40 hours per week, with a pay rate of approximately $70 per hour in the San Francisco Bay Area. Preference for onsite work in South San Francisco on Mondays and Tuesdays within a hybrid model.

Qualifications

• Strong project management, communication, problem-solving, and organizational skills.
• Proficiency with EDC, IRT, CTMS, and eTMF.

Responsibilities

• Managing day-to-day global clinical trial activities from study start-up through conduct and closeout.
• Supporting protocol review, feasibility assessments, site selection and activation, and protocol amendment activities.
• Managing CROs, sites, and clinical vendors, including oversight of plans, deliverables, timelines, budgets, and quality.
• Overseeing monitoring activities, including monitoring report review, site performance, data queries, and issue follow-up.

Job description

Reporting to the Executive Director, Clinical Operations, the contract Clinical Trial Manager (CTM) will manage the day-to-day operational execution of global clinical trials from study start-up through closeout. The contract CTM will be responsible for coordinating study activities, managing timelines and vendors, monitoring study and site performance, and working across functions to ensure study milestones and deliverables are achieved on time and to a high standard of quality.

This is a 6- to 12-month contract assignment offering approximately 40 hours per week. The anticipated pay rate is approximately $70 per hour for candidates in the San Francisco Bay Area. Candidates who can work onsite in South San Francisco on Mondays and Tuesdays as part of the company’s hybrid work model will be given preference. ADC clinical trial experience strongly preferred.

Qualified contractors should have experience that includes:

• Managing day-to-day global clinical trial activities from study start-up through conduct and closeout, including timelines, milestones, enrollment, and study performance.
• Supporting protocol review, feasibility assessments, site selection and activation, and protocol amendment activities.
• Managing CROs, sites, and clinical vendors, including oversight of plans, deliverables, timelines, budgets, and quality.
• Overseeing monitoring activities, including monitoring report review, U.S. co-monitoring, site performance, protocol deviations, data queries, and follow-up of significant issues.
• Identifying operational risks and working cross-functionally to develop and implement mitigation strategies.
• Leading study team meetings and communicating study progress, risks, decisions, and action items to internal and external stakeholders.
• Ensuring study conduct and TMF quality are consistent with study protocols, ICH/GCP, applicable regulatory requirements, and inspection-readiness expectations.
• Clinical operations experience in biotechnology, pharmaceutical, or CRO environments; ADC clinical trial experience strongly preferred.
• Strong project management, communication, problem-solving, and organizational skills; proficiency with EDC, IRT, CTMS, and eTMF.
• Ability to work effectively in a small, fast-paced biotech environment.

About ALX Oncology

ALX Oncology (Nasdaq: ALXO) is a clinical-stage biotechnology company advancing a pipeline of novel therapies designed to treat cancer and extend patients’ lives. ALX Oncology’s lead therapeutic candidate, evorpacept, has demonstrated potential to serve as a cornerstone therapy upon which the future of immuno-oncology can be built. Evorpacept is currently being evaluated across multiple ongoing clinical trials in a wide range of cancer indications. ALX Oncology’s second pipeline candidate, ALX2004, is a novel EGFR-targeted antibody-drug conjugate with a differentiated mechanism of action. A Phase 1, dose-escalation trial of ALX2004 is ongoing in patients with EGFR-expressing solid tumors. More information is available at www.alxoncology.com and on LinkedIn @ ALX Oncology .